healthy volunteers
Conditions
Interventions
moxifloxacin 400 mg
placebo
Sponsors
Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: A subject is considered eligible for participation in the trial if the following inclusion criteria are satisfied at the screening visit or at baseline: 1. Healthy males between the ages of 18 and 45 years at the time of Screening 2. Body weight between 50-100 kg and body mass index (BMI) within 18-28 kg/m2 at screening 3. Current non-smokers who have not used any nicotine-containing products (chewed or smoked) in the year prior to screening. 4. Willing to communicate with the investigator and site staff and comply with all study procedures and requirements; 5. Able to provide written, informed consent including compliance with the requirements listed in the consent form.
Exclusion criteria
Exclusion criteria: 1.Past or present diseases, which as judged by the investigator, may affect the outcome of this study, include, but not limited to, significant medical abnormality including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic, or autoimmune disorder 2. Positive for HIV, hepatitis B and/or hepatitis C at screening 3. Family history of QTc prolongation or of unexplainable sudden death at <50 years of age 4. Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders 5. Any condition that may interfere with the absorption, metabolism, or elimination of the study drug 6. History of, or active, alcohol or illicit drug abuse. Alcohol abuse is defined as an average intake of three or more drinks (12 oz beer, 1.5 oz of hard liquor, or equivalent) per day 7. Tobacco use (chewed or smoked) unless abstinent for at least one month 8. Laboratory safety test results that are outside of the normal reference ranges (unless clinically acceptable to the Principal Investigator) or are clinically significant abnormalities as determined by the Principal Investigator 9. At screening: resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute (may be repeated once at the discretion of the Investigator). Minor deviations will be acceptable if considered to be of no clinical significance by the Investigator. 10. At screening: resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg. Blood pressure measurements may be repeated once at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time matched difference of delta-delta QTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Japanese and Caucasian subjects under the same exposure ( Cmax ) of Moxifloxacin | — |
Countries
Japan,North America
Contacts
Public ContactYuji Kumagai
Kitasato University East Hospital Clinical Research Center
Outcome results
None listed